Generic Challenge:. Martin a. Voet

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Drug Industry Regulation

       Drug Development

       Pre-clinical Development

       Clinical Development: Phases I–IV

       Well-controlled Studies

       Accelerating NDA Approvals

       Types of Drug Filings

       Biologically Derived Drugs

       Antibiotics

       Medical Devices

       Right-to-try State Laws

       Drug Agencies Outside the U.S.

       Europe

       Japan

       Take Home Message

Chapter 5

Exclusivity for Brand Name Innovative Drug Products

       Exclusivity in General

       Patent Exclusivity

       Regulatory Exclusivity

       Orphan Drug Exclusivity

       New Chemical Entity (NCE) Exclusivity

       New Use/Condition of Use/Formulation Exclusivity

       Pediatric Exclusivity

       Qualified Infectious Disease Products (QIDP)

       Other Forms of Exclusivity

       Litigation Exclusivity

       Exclusivity outside the U.S.

       European Union

       Japan

       China, Australia, New Zealand and Canada

       India

       Take Home Message

Chapter 6

Generic Drugs: Hatch Waxman Act

       Historical Background

       The Law Today

       FDA Orange Book

       Patents Listed in the Orange Book

       Patent Certifications

       Suits Following Patent Certification

       Therapeutic Equivalence Rating

       Patent Use Codes

       Litigation on Scope of Patent Use Codes

       180-day Generic Product Exclusivity

       Authorized Generics

       Medicare Act Amendments

       Declaratory Judgment Actions

       Counterclaim to De-list from the Orange Book

       Agreements between Innovators and Generics

       Settlement Agreements in Europe

       Orphan Exclusivity to Block Generic Approval?

       ANDA Backlog

       Patent Challenges on the Increase

       Inter Partes Review in Hatch Waxman Cases

       Canada

       In General

       Paragraph IV Type Letters

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